Department of Pneumology, Hôpital d'Instruction des Armées Sainte-Anne, Toulon, France; Ecole du Val-de-Grâce, Paris, France.
Normandie Univ, UNIROUEN, LITIS Lab QuantIF team EA4108, CHU Rouen, Department of Pneumology and Inserm CIC-CRB 1404, F-76000 Rouen, France.
Lung Cancer. 2024 Aug;194:107866. doi: 10.1016/j.lungcan.2024.107866. Epub 2024 Jun 29.
First-line standard-of-care for unresectable, pleural mesothelioma (PM) changed with the phase 3 CheckMate 743 study results, showing that nivolumab plus ipilimumab (Nivo + Ipi) significantly extended overall survival (OS) versus platinum + pemetrexed chemotherapy for PM (median OS 18.1 versus 14.1 months; hazard ratio: 0.74; p = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results.
This French multicenter, retrospective cohort study was undertaken to assess the outcomes of treatment-naïve PM patients given Nivo + Ipi via an early-access program (EAP). The primary objective was investigator-assessed real world -progression-free survival (PFS). The secondary objectives were the combination's -overall survival (OS) and safety.
From 1 April 2021 to 15 Feb 2022, the analysis included 201 of the 305 EAP-enrolled patients treated in 63 centers (79.6 % men; median age: 75 years; 91.8 % Eastern Cooperative Oncology Group performance status (ECOG-PS) 0/1; 74.5 % epithelioid histology). With median (95 % CI) follow-up for all patients of 18.4 (17.7-19.2) months, -PFS and OS were 6.3 (5.3-7.5) and 18.9 (17.6-not reached (NR)) months, with 1-year OS at 66.4 % (60.1-73.3 %). Median OS and 1-year survival rates were 21.0 (18.7-NR) and 70.8 % (63.9 %-780.6 %), and 14.1 (10.9-21.0) months and 54.9 % (42.8 %-70.4 %) for epithelioid and non-epithelioid PM subgroups, respectively. PFS was equal between the two subgroups. Grade 3-4 adverse events occurred in 23.3 % of patients and three deaths were treatment-related.
For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.
对于不可切除的胸膜间皮瘤（PM），一线标准治疗随着三期 CheckMate 743 研究结果而改变，结果表明纳武利尤单抗联合伊匹单抗（Nivo+Ipi）显著延长了 PM 的总生存期（OS），与铂类+培美曲塞化疗相比（中位 OS 18.1 个月 vs. 14.1 个月；风险比：0.74；p=0.002）。需要真实世界（rw）数据来确认这些结果。
这项法国多中心回顾性队列研究旨在评估接受早期准入计划（EAP）的未经治疗的 PM 患者的 Nivo+Ipi 治疗的疗效和安全性。主要终点是研究者评估的真实世界无进展生存期（PFS）。次要终点是该联合治疗的总生存期（OS）和安全性。
自 2021 年 4 月 1 日至 2022 年 2 月 15 日，该分析纳入了 305 名 EAP 入组患者中的 201 名患者，这些患者在 63 个中心接受治疗（79.6%为男性；中位年龄：75 岁；91.8%的东部肿瘤协作组表现状态（ECOG-PS）为 0/1；74.5%为上皮样组织学）。所有患者的中位（95%CI）随访时间为 18.4（17.7-19.2）个月，-PFS 和 OS 分别为 6.3（5.3-7.5）和 18.9（17.6-NR）个月，1 年 OS 率为 66.4%（60.1%-73.3%）。中位 OS 和 1 年生存率分别为 21.0（18.7-NR）和 70.8%（63.9%-780.6%），上皮样和非上皮样 PM 亚组分别为 14.1（10.9-21.0）个月和 54.9%（42.8%-70.4%）。PFS 在两个亚组之间是相等的。3 级或 4 级不良事件发生在 23.3%的患者中，有 3 例死亡与治疗相关。
对于这一未经选择的 PM 人群，疗效和安全性结果与 CheckMate 743 试验结果相当。
